Reprocessing of Implants - Sociedad de enfermeras en … · · 2015-07-01Issue of reprocessing of...
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Transcript of Reprocessing of Implants - Sociedad de enfermeras en … · · 2015-07-01Issue of reprocessing of...
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Reprocessing of Implants:What are the Issues?
Dr. Michelle J. Alfa, Ph.D., FCCMMedical Director, Clinical Microbiology,
Diagnostic Services of Manitoba, Winnipeg, Canada
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Hear no evil.
See no evil.
Speak no evil.
Surgical Instrument Sets:When You Open Pandoras Box.
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Overview:
Implants: what causes implant failure?
Issue of reprocessing of implants
Published data- effect of foreign material on implant- effect of repeated sterilization
What can users do?
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Implants:
Joint replacement:- cement- screws, nails, wires
Bone repair:- Broken bones:
plates, rods, screws, wires
Spine: - repair fractures/abnormalities- stabilize
Pictures from Goggle Images; March 2, 2010
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Implants
Implants are Single use devices (SUDs)
Implants include:- joints, brackets, rods, etc- screws, wires used to immobilize implant
Variable composition:- stainless steel (most common)- titanium- polymers (e.g. polyethylene)
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What causes Primary implant failure Revision surgery?
Total Hip Arthroplasty:
Aseptic loosening: 51%
Instability: 15%
Wear: 14%
Infection 8%
Jarari SM et al. Revision Hip Arthroplasty Infection is the most common cause of failure. Clin Orthop Relat Res;2010:
Reviewed 1366 Total Hip Arthroplasty Revisions
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What causes Revision failure?
Revised Total Hip Arthroplasty:
Aseptic loosening: 19.4%
Instability: 25.1%
Infection 30.2%
Jarari SM et al. Revision Hip Arthroplasty Infection is the most common cause of failure. Clin Orthop Relat Res;2010:
Reviewed 1366 Total Hip Arthroplasty Revisions
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Screws to hold
implant in place
Implants used to
stabilize bone: SUD
Example: Fragment Tray Surgical set (ORSY-690SMSET )
Picture from Synthes website; March 2, 2010
Surgical instruments
used for surgery
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Issue of Reprocessing of Implants
Stainless steel brackets, screws, rods, wires are implants but are treated like surgical instruments- washed, steam sterilized repeatedly until used
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Reprocessing of Instrument Trays:Washer Disinfectors
Pre-treatment: enzymatic detergent
Cleaning: chemical detergent
Final Rinse: Tap water (or Deionized, RO)
Steam
Every time instrument set is exposed to:
CLEANING:
STERILIZATION:
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What Residuals are Relevant?
Viable Microorganisms:- previous patient- water
Organic:- previous patient- water- detergent- biofilm (washer or instruments)
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Manufacturers Instructions:All state that cleaning instructions are validated
Not clearNoNo7. Smith & Nephew
StatedNoNo6. Ulrich Med
StatedNoNo5. Medacta
StatedNot statedNo4. Wright
StatedYesYes3. Stryker
StatedYesYes2. Zimmer
StatedNot statedNo1. Synthes
Dont reprocess screws if soiled
Cleaning validated for screws
Screws defined as implants
Manufacturer
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YesDI preferredNot stated7. Smith & Nephew
YesPurified waterRemove6. Ulrich Med
YesDI or purifiedNot stated5. Medacta
YesDI or RONot stated4. Wright
YesPurified waterRemove3. Stryker
YesPurified waterLeave in set2. Zimmer
YesDI or PURWNot stated1. Synthes
User validation required for cleaning
Final rinse with high quality water
Remove Screws from Tray set to reprocess
Manufacturer
Manufacturers Instructions:All state that cleaning instructions are validated
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Published Data: Is there anything to worry about?
Surgical instruments; residuals?
Implants; what causes aseptic loosening?
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13464.10 18.14 264.47 138.92 Average:
25373.88 10.58 193.46 141.14
5. Skin Hook1/5 visibly soiled:
(1 device; 1+)
13.14 23.44 138.76 169.40
4. Toothed Adson forcep (fine)4/5 visibly soiled:
(2 devices; 1+, 2 devices; 2+)
20.42 32.40 352.10 146.68
3. Curved Iris Scissors2/5 visibly soiled:
(2 devices; 3+)
23667.74 10.62 336.86 116.86
2. Fine Needle Driver5/5 visibly soiled:
(2 devices; 1+, 3 devices; 3+)
18245.32 13.68 301.16 120.52
1. Curved Mosquito forcep1/5 visibly soiled:
(1 device; 1+)
After
cleaning
Before
cleaning
After
cleaning
Before
cleaning
Plastics TrayInstrument type:
(visible soil after use)
Endotoxin: (EU/cm2)
Average for 5 devices (SD)
Carbohydrate: (g/cm2)
Average for 5 devices (SD)*
Residuals on Patient-used instruments post-cleaning: Automated washer
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Pathology of Aseptic loosening
All pictures from: T Bauer & J Schils Skeletal Radiol 1999;28:483-497
1. Wear particles: metal or polyethylene
2. Inflammatory response: T-cells, macrophages, Giant cells
Polyethylene knee implantStainless steel hip implant
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Residuals: Orthopaedic implants
Measurement and removal of adherent endotoxin from titanium particles and implant surfaces. Regab AA et al , J Orthop Res 1999;17:803-809
Adherent endotoxin on orthopaedicwear particles stimulates cytokine production and osteoclastdifferentiation. Bi Y et al, J Bon Miner Res 2001;16:2082-2091
Accumulation of LPS by polyethylene particles decreases bone attachment to Implants. Xing Z et al, J Orthop Res 2006;24:959-966
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Impact of LPS-particles on implant attachment in bone
0
5
10
15
20
25
No partic
lesPart
icles
LPS-part
icles
Bone-implant attachment %
Xing Z et al J Orthop Res 2006;24:959-966
RAT MODEL;LPS-coated particles + titanium pins implanted in femoral canal
Assessed 6 weeks post-surgery by MicroCT
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Inflammatory Response:
The finding of only T cells has caused us to propose, and continue to seek evidence for, an immunological
reaction in the presence of wear debris.
Review: The combined role of wear particles, macrophages and lymphocytes in the loosening of total joint prostheses.
P A Revell J. R. Soc. Interface 2008;5:1263-1278
Picture from: T Bauer & J Schils Skeletal Radiol 1999;28:483-497
Aggregate of corrosion particles
Dark particles: metallic debris
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Impact of repeated rounds of steam sterilization; stainless steel 7 mm sternal wire
Increased oxide particle accumulation after repeated rounds of steam sterilization
Increased corrosion after ten rounds of steam sterilization (121o C; 30 mins)
Pictures from: Chun-Che Shih et al Degradation of 316L Stainless steel sternal wire by steam sterilization. Acta Biomaterialia 2010
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Summary of Published Literature:
Rat Model: LPS and particulate wear debris inflammatory response/loosening
LPS does stimulate inflammatory responseTNF, IL-1, IL-6, PGE2
High LPS residuals on instruments after final rinse in automated washer-disinfector
Repeated steam sterilization destroys passivation of stainless steel and increases oxide thickness
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Pandoras Box!!
Do residuals from reprocessing contribute to aseptic implant loosening?
What impact does repeated steam sterilization have on strength of screws, nails etc?
How frequently should these items be replaced?
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What can Users do??
Testing to assure the WD is cleaning properly
Ensure final rinse water of adequate quality
Individual packaging of plates, screws, wires problematic
More Scientific Data needed:Assess screws, etc that are repeatedly reprocessed any LPS or organic residuals?
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References
General Reprocessing AAMI TIR12:2004 Designing, testing, and labeling reusable medical
devices for reprocessing in health care facilities: A guide for medical device manufacturers, 2ed
Red brochure: Proper Maintenance of Instruments, 8ed.http://www.a-k-i.org/englisch/lit.htm
Spaulding EH. Chemical disinfection of medical and surgical materials [Chapter 32]. In: Lawrence CA, Block SS, eds. Disinfection, sterilization and preservation. Philadelphia, PA: Lea & Febiger, 1968: 51731
Provincial Infectious Diseases Advisory Committee (PIDAC) MOHLTC Best Practice Practices for Cleaning, Disinfection and Sterilization In all Health Care Settings (April 30, 2006)
CDC (HICPAC) Guideline for Disinfection and Sterilization in Healthcare Facilities 2008
ISO 15883-1:2006. Washerdisinfectors, Part 1: General requirements, definitions and tests.
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References
Cleaning
AAMI TIR34:2008 Water for reprocessing medical devices
AAMI TIR30:2003 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices
ISO/TS 15883-5:2005 Washer-disinfectors Part 5:Test soils and methods for demonstrating cleaning efficacy of washerdisinfectors
Reprocessing Instructions & Methods
AAMI TIR12:2004 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers, 2ed
ANSI/AAMI ST81:2004 Sterilization of medical devicesInformation to be provided by the manufacturer for the processing of resterilizable medical devices
ANSI/AAMI ST79:2006 Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Canadian Standards Association Inc. Publishers Mississauga, ON. CSA Z314.8-08 Decontamination of Reusable Medical Devices. 2008.